Bone plate trial

ABSTRACT

Disclosed herein are a reversible bone plate template and a method for using the same to size an implant. The bone plate template may include first and second portions. The second portion may be wider than the first portion and asymmetrical about a longitudinal axis. A section between the first and second portions may allow the second portion to be moved between first and second positions such that either a first or a second surface may be a bone contacting surface. A method for sizing an implant with a bone plate template may include determining whether a first or second surface is to be placed on bone, moving a portion of the bone plate template, placing it on bone and selecting an implant based upon the bone plate template.

CROSS-REFERENCE TO RELATED APPLICATION

The present application claims the benefit of the filing of U.S.Provisional Patent Application No. 62/434,669, filed Dec. 15, 2016, thedisclosure of which is hereby incorporated herein by reference.

BACKGROUND OF THE INVENTION

The present invention relates to an apparatus and method for sizing boneimplants, and in particular a reversible bone plate trial and a methodfor using a reversible bone plate trial for sizing purposes.

Bone plates are used in the treatment of bone fractures to hold togetherbroken pieces of bone to allow proper healing of broken bones. Boneplates come in different configurations and have varying shapes andsizes. These configurations are specifically adapted for, inter alia,fracture location, fracture characteristics, and variations in humananatomy. Selecting the correct bone plate and determining the optimalposition to affix the plate on the bone is crucial for successfultreatment of bone fractures. However, determining the correct size ofthe bone plate to be used, as well as the position in which it is to beaffixed to the bone can be challenging.

Typically, an x-ray serves as a scan of the fracture to allow thesurgeon to generally select the appropriately sized bone plate, andwhere it should optimally be affixed to the bone. Preoperative planning,however, may not be sufficient to properly determine the correct sizeand positioning for a bone plate. Thus, bone plate trials are providedand allow surgeons to choose the appropriate bone plate and determinethe position intraoperatively, which provides for more precise boneplate selection and positioning.

Bone plate trials themselves may come in many configurations to matchfracture patterns and anatomical variations. Surgeons typically placebone plate trials against the fractured bone to test for appropriatesize and positioning. A trial-and-error procedure is used whereby thesurgeons tests different bone plate trials, until the correct bone platetrial is identified. This trial-and-error procedure increases the effortand duration of the surgery, especially when asymmetric bone platesconfigured for use on either left or right anatomical structures arerequired. For example, fractures of the distal radius may requirespecific bone plate trials that are configured for either the left orright distal radius, and consequently require multiple sets of boneplate trials—i.e., a first set for the right distal radius, and a secondset for the left distal radius. This places an additional burden on thesurgeon to ensure that a bone plate corresponding to the specific sideof the anatomy is selected.

Contourable bone plate trials may reduce the number of trial platesrequired, wherein a surgeon may be able to shape the bone plate trial toalign with the anatomy of the fractured bone. However, rigid contourableplate trials may require substantial force to deform them toanatomically alignment, whereas soft contourable plate trials, which maybe deformed by hand, are prone to kinks and folds resulting in impropersizing. Therefore, suitable improvements in bone plate trials arerequired.

BRIEF SUMMARY OF THE INVENTION

Disclosed herein are bone plate templates and methods for sizing animplant with a reversible bone plate template.

In a first aspect of the present invention, a bone plate template isprovided. The bone plate template may include a first surface, a secondsurface, a first portion, a second portion, and a section. The secondsurface may be opposite the first surface. The second portion may bewider than the first portion and asymmetrical about a longitudinal axisextending between the first and second portions. The section may bebetween the first and second portions. The section may allow the secondportion to be moved to first and second positions with respect to thefirst portion. When the second portion is in the first position, thefirst surface may be a bone contacting surface, and when the secondportion is in the second position, the second surface may be the bonecontacting surface.

In accordance with the first aspect, the second portion may be moved tothe first and second positions with respect to the first portion bydeforming the section along a bending axis substantially transverse tothe longitudinal axis. The bone plate template may be elasticallydeformed about the bending axis.

Further in accordance with the first aspect, the section may be selectedfrom the group consisting of grooves, slots and notches.

Still further in accordance with the first aspect, the second portionmay be contoured to substantially match a volar surface of a distalradius. The section may be located at a metaphyseal region of the distalradius.

Still further in accordance with the first aspect, the first positionmay allow for the bone plate template to be placed on a right distalradius and the second position may allow for the bone plate to be placedon a left distal radius. In the first and second positions, the secondportion may be aligned with a volar tilt of the distal radius.

In other aspects, the template may further comprise a plurality ofmarkings. The plurality of markings may be located near the firstportion of the bone plate template. The plurality of markings may beselected from the group consisting of grooves, slots and notches.

A second aspect of the present invention is a method of sizing animplant. A method in accordance with this aspect of the invention mayinclude the steps of providing a bone plate template having a first anda second surface, determining whether the first or second surfaces areto be placed on a bone, moving a second portion of the bone plate from afirst position to a second position, placing the bone plate template onthe bone, and selecting an implant based upon the bone plate template.The step of determining whether the first or second surfaces are to beplaced on the bone may be based upon the configuration of the secondportion with respect to the bone. The second portion may be moved fromthe first position to the second position with respect to the firstposition.

The method may further include the step of determining a length of theimplant based upon at least one marking on the first portion. The secondportion may be larger than the first portion and asymmetrical about alongitudinal axis extending between the first and second portions. Thebone may be a distal radius and the placing step may include placing thebone template on a volar surface of the distal radius.

BRIEF DESCRIPTION OF THE DRAWINGS

A more complete appreciation of the subject matter of the presentinvention and the various advantages thereof can be realized byreference to the following detailed descriptions, in which reference ismade to the accompanying drawings:

FIG. 1 is a perspective view of a bone plate trial according to oneembodiment of the present invention;

FIG. 2A is a front view of the bone plate trial of FIG. 1 in a firstposition;

FIG. 2B is a front view of the bone plate trial of FIG. 1 in a secondposition;

FIG. 3A is side elevation view of the bone plate trial of FIG. 1 in thefirst position;

FIG. 3B is a side elevation view of the bone plate trial of FIG. 1 inthe second position;

FIGS. 4A-4D are side elevation views of a bending section depictingvarious embodiments of the bending section;

FIG. 5A is front view of a bone plate trial according to anotherembodiment of the present invention in a first position;

FIG. 5B is a front view of the bone plate trial of FIG. 5A in a secondposition; and

FIG. 6 is a front view of the bone plate trial of FIG. 1 placed over abone fracture.

DETAILED DESCRIPTION

In describing preferred embodiments of the disclosure, reference will bemade to directional nomenclature used in describing the human body. Itis noted that this nomenclature is used only for convenience and that itis not intended to be limiting with respect to the scope of theinvention. As used herein, when referring to bones or other parts of thebody, the term “proximal” means closer to the heart and the term“distal” means more distant from the heart. The term “medial” meanstoward the midline of the body and term “lateral” means away from themidline of the body.

FIG. 1 depicts a bone plate trial 100 for sizing a distal radius plate(not shown). Bone plate trial 100 includes a tail section 102, a bodysection 104, and a head section 106. Head section 106 comprises anulnar-side section 110 and a radial-side section 112. As shown in FIG.1, the profile of ulnar-side section 110 is different from theradial-side section 112, and therefore head section 106 is asymmetricabout a longitudinal axis L1 extending across bone plate trial 100. Inparticular, ulnar-side section 110 extends more distally thanradial-side section 112. One or more apertures 114 are present acrosshead section 106. Apertures 114 allow K-wires or screws to temporarilyfix bone plate trial 100 on bone. Apertures 114 shown here are circular,but other aperture configurations, such as triangular, rectangular,etc., may also be used.

A bending section 108 separates head section 106 from body section 104.The bending section allows head section 106 to be bent along an axis L2with respect to body section 104. Bending section 108 may include of anyof grooves, slots, notches, and a flexible portion as more fullyexplained below. Body section 104 includes additional aperturesincluding an oblong aperture 116 as shown in FIG. 1, which may allowaccess for certain tools such as a drill bit or other tooling withmarking capabilities. Oblong aperture 116 may also serve as openings fork-wire implantation to allow for subsequent positioning of bone platetrial 100. Markings or other indicators may also be present on bodysection 104 to facilitate bone plate sizing and positioning.

A band 122 is located between body section 104 and tail section 102.Band 122 may be a continuous linear slot extending transversely acrossbone plate trial 100 as shown in FIG. 1 and may include any of grooves,slots and notches (not shown). Band 122 may facilitate in bending tailsection 102 relative to body section 104 to allow for anatomicalalignment of bone plate trial 100. Band 122 may also be configured to bedetachable from body 104 to create a shorter bone plate trial 100 ifnecessary.

FIGS. 2A, 3A and 2B, 3B show bone plate trial 100 in a first and secondposition, respectively. Bone trial 100 has a first surface 118 and anopposite second surface 120. In the first position, second surface 120is the bone contacting surface as best shown in FIG. 3A. Whereas in thesecond position, the first surface 118 is the bone contacting surface asbest shown in FIG. 3B. The side elevation views of FIGS. 3A and 3B ofbone plate trial 100 further illustrate the bending of head section 106with respect to body section 104. In the first position shown in FIG.3A, head section 106 is rotated along bending section 108 as indicatedby rotation arrow 130 to align bone plate trial 100 with a volar tilt ofa left distal radius 124.

Bone plate trial 100 can also be used for a right distal radius 132 asshown in FIG. 3B. Head section 106 is rotated along bending section 108as indicated by rotation arrow 130 until head section 106 is alignedwith the volar tilt of right distal radius 132. In this second position,first surface 108 serves as the bone contacting surface. Hence, boneplate trial 100 can be used on a left distal radius 124 (FIGS. 2A and3A) or on a right distal radius 132 (FIGS. 2B and 3B) by reversing thebone contacting surface and rotating head section 106 to align with therespective volar tilt.

FIGS. 4A-4D show details of the bending section depicting variousembodiments. The bending section may include grooves or notches such asa rectangular groove 108 (FIG. 4A), a V-shaped groove 208 (FIG. 4B), ora U-shaped groove 308 (FIG. 4C). Alternatively, the bending section mayinclude a bending band 408. Bending band 408 may be a malleable materialwith a lower elastic modulus than head section 106 and body section 104,and consequently allow head section 106 to be bent with reference tobody section 104.

Referring now to FIGS. 5A and 5B, there is shown another embodiment ofthe present invention in the form of a bone plate trial 500 for sizing atibial bone plate. Bone plate trial 500 is similar to bone plate trial100, and therefore like elements are referred to with similar referencenumeral within the 500-series of numbers. Bone plate trial 500 isconfigured to be used as reversible trial for sizing tibial bone platesfor either left or right tibial fractures, whereby either a firstsurface 518 or a second surface 520 may be the bone contacting surface.Bending sections at 508 and 522 allow bone plate trial 500 to be alignedwith the left or right tibia. In a first position, second surface 520serves as the bone contacting surface to be placed on a right tibia, andin a second position, first surface 518 serves as the bone contactingsurface to be placed on a left tibia.

In a method according to a further aspect of the present invention, boneplate trial 100 is used to size a bone plate. As more fully explainedabove, bone plate trial 100 may be used on either a left or right distalradius. A surgeon selecting a distal radius bone plate trial to size adistal radius bone plate may only need to select a bone plate trial thatcovers fracture 126 as best shown in FIG. 6. Once a reversible boneplate trial 100 is selected, the surgeon may determine if first surface118 or second surface 120 must be placed the distal radius depending onwhether the fracture is on the right or left distal radius. Asillustrated in this example, the surgeon may then place the selectedbone plate trial on right distal radius 132 shown in FIG. 6, and bendhead section 106, and tail section 102 if necessary, to align bone platetrial 100 with the volar tilt of right distal radius 132. After selectedbone plate trial 100 is properly positioned on right distal radius 132,the surgeon may use apertures 114 to temporarily fix bone plate trial100 by using K-wires or screws. Oblong aperture 116 may also be used tomake temporary markings on right distal radius 132 with marking toolssuch as a drill bit with laser marking capability. If, after placing,the selected bone plate trial on fracture 126, the surgeon realizes thatbone plate trial 100 does not optimally cover fracture area—i.e., islarger or smaller than necessary, the surgeon may simply proceed toselect a larger or smaller bone plate trial as required, and repeat thesame steps. Alternatively, if the selected bone plate trial is largerthan required, the surgeon may remove trial section 102 by detaching itfrom body section 104 along band 122 to readily adjust length of boneplate trial 100 without having to select a new bone plate trial.Ultimately, a bone plate corresponding to the most suitable trial isselected and implanted. K-wires, screws or markings that were utilizedor implanted/made with trial 100 can aid in this implantation.

While the present disclosure exemplifies reversible bone plate trial fordistal radius and tibial fractures, bone plate trials disclosed hereinmay be used in treatment of a wide variety of fractures includingfractures of the ulna, phalanges, humerus, femur, etc.

Bone plate trials of the present disclosure may be, but are not limitedto, being made of any polymer such as polyetheretherketone (“PEEK”),polyarlyetherketones (“PAEK”), ultra-high molecular weight polyethylene(“UHMWPE”), metals such as titanium, stainless steel, aluminum, or othersuitable material (e.g., ceramic) that is biocompatible and possesssufficient strength and rigidity. Bone plate trials may also includemarkings 128 to aid in sizing and positioning as shown in FIG. 6.Marking 128 may also denote bone contacting surface for the left orright distal radius or another anatomical feature. Radio-opaque markersmay be used to facilitate sizing and positioning of the bone platetrials of the present disclosure.

Furthermore, although the invention disclosed herein has been describedwith reference to particular features, it is to be understood that thesefeatures are merely illustrative of the principles and applications ofthe present invention. It is therefore to be understood that numerousmodifications, including changes in the sizes of the various featuresdescribed herein, may be made to the illustrative embodiments and thatother arrangements may be devised without departing from the spirit andscope of the present invention. In this regard, the present inventionencompasses numerous additional features in addition to those specificfeatures set forth in the paragraphs below. Moreover, the foregoingdisclosure should be taken by way of illustration rather than by way oflimitation as the present invention is defined in the examples of thenumbered paragraphs, which describe features in accordance with variousembodiments of the invention, set forth in the claims below.

The invention claimed is:
 1. A bone plate template comprising: a firstsurface; a second surface opposite the first surface; a first rigidportion; a second rigid portion that is wider than the first rigidportion and asymmetrical about a longitudinal axis extending between thefirst and second rigid portions; a first section between the first andsecond rigid portions, the first section having a first groove on thefirst surface and a second groove on the second surface, the first andsecond grooves allowing the second rigid portion to be moved to firstand second positions with respect to the first rigid portion; and asecond section extending between the first rigid portion and a tailportion, the second section including any of a bendable or detachableelement, wherein when the second rigid portion is in the first positionthe first surface is a bone contacting surface and when the second rigidportion is in the second position the second surface is the bonecontacting surface, wherein the second section includes a bendableelement configured to allow the tail portion to be moved with respect tothe first rigid portion.
 2. The bone plate template of claim 1, whereinthe second rigid portion is moved to the first and second positions withrespect to the first rigid portion by deforming the first section alonga bending axis substantially transverse to the longitudinal axis.
 3. Thebone plate template of claim 2, wherein the bone plate template may beelastically deformed about the bending axis.
 4. The bone plate templateof claim 1, wherein the first and second grooves include slots andnotches.
 5. The bone plate template of claim 1, wherein the second rigidportion is contoured to substantially match a volar surface of a distalradius.
 6. The bone plate template of claim 5, wherein the first sectionis located at a metaphyseal region of the distal radius.
 7. The boneplate template of claim 1, wherein the first position allows for thebone plate template to be placed on a right distal radius and the secondposition allows for the bone plate to be placed on a left distal radius.8. The bone plate template of claim 7, wherein in the first and secondpositions, the second rigid portion is aligned with a volar tilt of thedistal radius.
 9. The bone plate template of claim 1, wherein the boneplate template further comprises a plurality of markings.
 10. The boneplate template of claim 9, wherein the plurality of markings are locatednear the first rigid portion of bone plate template.
 11. The bone platetemplate of claim 9, wherein the plurality of markings is selected fromthe group consisting of grooves, slots and notches.
 12. The bonetemplate of claim 1, wherein the second section includes a detachableelement configured to allow tail portion to be detached from the firstrigid portion.
 13. A bone plate template comprising: a first surface; asecond surface opposite the first surface; a first portion; a secondportion that is wider than the first portion and asymmetrical about alongitudinal axis extending between the first and second portions, afirst section between the first and second portions, the first sectionhaving a top surface recessed from the first surface and a bottomsurface recessed from the second surface such that the second portioncan be moved to first and second positions with respect to the firstportion; and a second section extending between the first portion and atail portion, the second section including any of a bendable ordetachable elements, wherein when the second portion is in the firstposition the first surface is a bone contacting surface and when thesecond portion is in the second position the second surface is the bonecontacting surface, wherein the second section includes a detachableelement configured to allow tail portion to be detached from the firstportion.
 14. The bone plate template of claim 13, wherein the secondsection includes a bendable element configured to allow the tail portionto be moved with respect to the first portion.